近日,EDQM发布关于欧洲药典不再发布纸质版,并将发布仅支持在线形式的药典的公告,EDQM将于2025年6月推出仅限在线的欧洲药典。从12.1版开始,欧洲药典将仅提供在线版本,在线版欧洲药典内容包含现行、待实施和某些以前的欧洲药典版本,并支持强大的搜索工具、信息中心和新的筛选工具和属性无缝地检索到他们需要的内容。第 11 版的所有用户在过渡期内仍然保持有效,直到 2025 年底。自 2026 年 1 月1 日起,用户将只能订阅在线版本。
翻译如下:
A new era for the European Pharmacopoeia – Online-only format from June 2025
欧洲药典的新时代 – 2025 年 6月起仅在线版本
EDQM Strasbourg, France 07/11/2024
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will launch the online-only European Pharmacopoeia (Ph. Eur.) in June 2025, bringing legally binding European pharmacopoeial standards to subscribers in a modern and easier-to-use format. The discontinuation of the printed version is a step towards becoming more environmentally friendly. A great set of new features in the new online platform will improve the user experience at all levels and enable the Ph. Eur. to better meet subscribers’ needs for years to come.
EDQM将于2025年6月推出仅限在线的欧洲药典,以现代且易于使用的格式为用户带来具有法律约束力的欧洲药典标准。停止印刷版是朝着更加环保的方向迈出的一步。新在线平台中的大量新功能将改善各个级别的用户体验,并使Ph. Eur. 能够更好地满足用户未来几年的需求。
Online-only 12th Edition
仅限在线的第12版
Starting with issue 12.1, the Ph. Eur. will be available exclusively online, with all texts – current, pending implementation and certain previous editions of the Ph. Eur. – available to subscribers on an improved, user-friendly platform combining a modern, intuitive interface with dynamic visuals. Users will be guided seamlessly to the content they need through powerful search tools, a dashboard and new filters and attributes.
从12.1版开始,欧洲药典将仅提供在线版本,所有文本(现行、待实施和某些以前的欧洲药典版本)都将在一个改进的、用户友好的平台上提供给用户,该平台将现代、直观的界面与动态的视觉效果相结合。用户将通过强大的搜索工具、信息中心和新的筛选工具和属性无缝地检索到他们需要的内容。
New publication model
新的发布模式
The former three-year cycle comprising one edition and eight supplements will be replaced by an annual edition made up of three issues, numbered .1 to .3 (for example, the 12th Edition will consist of issues 12.1, 12.2 and 12.3). Each of these issues will contain the new and revised texts adopted at one of the three European Pharmacopoeia Commission (EPC) sessions held annually. What will not change is the implementation schedule, which remains January, April and July, respectively, of the year following publication of a text. A detailed calendar presenting the EPC sessions and adoption and implementation dates will be published in due time.
之前由 1 个版本和 8 个增补组成的三年周期将被由3 个年度版本所取代,编号为 .1 至 .3(例如,第 12 版将包括第 12.1、12.2 和 12.3 )。每一版都包含欧洲药典委员会 (EPC) 会议上通过的新文本和修订文本。不会改变的是实施时间表,分别是发布后一年的 1 月、4 月和 7 月。将适时发布介绍 EPC会议以及采用和实施日期的详细日程。
365-day licence
365天许可
A 365-day licence will also be introduced, with simplified licence management.
还将引入 365 天许可,简化许可管理。
Transitional period
过渡期
All subscriptions to the 11th Edition will remain valid during the transitional period until the end of 2025. As of 1 January 2026, users will only be able to subscribe to the online version.
第 11 版的所有用户在过渡期内保持有效,直到 2025 年底。自 2026 年 1 月1 日起,用户将只能订阅在线版本。
公众号
GMP办公室
专业的GMP合规性研究组织
国内外(FDA、EMA、MHRA、CFDA、WHO、PIC/S等)GMP法规解读;
国内外制药行业GMP监管动态;
GMP技术指南(ISPE、PDA、ISO、ASTM等)分享